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U.S. Department of Health and Human Services

510(K) Premarket Notification
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Device Name
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510(K)
Number
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Decision
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card guard personal electrocardiogram transmitter, model cg-6206/6306 Card Guard Scientific Survival , Ltd. k000225 02/11/2000
single size tendon spacer Medist International k000019 03/29/2000
yoshida wave pict cam intraoral camera, sigma biomedics sigmacam intraoral camera The Yoshida Dental Mfg. Co., Ltd. k000577 05/05/2000
ebi xfix dfs metaphyseal correction system Ebi, L.P. k001358 05/23/2000
thermage thermacool system Thermage, Inc. k000944 07/19/2000
wako autokit lp(a)/express 550 Wako Chemicals USA, Inc. k001921 07/23/2000
howmedica osteonics modular rotating hinge knee Howmedica Osteonics Corp. k002552 11/13/2000
thermage thermacool ii system Thermage, Inc. k003183 12/08/2000
thromborel s Dade Behring, Inc. k003870 02/20/2001
m2376a devicelink system Agilent Technologies, Inc. k010453 03/02/2001

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